3-amino-p-toluamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000 -2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study was carried out according to test guidline OECD401 and under GLP-conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-p-toluamide

EC Number:

243-039-0

EC Name:

3-amino-p-toluamide

Cas Number:

19406-86-1

Molecular formula:

C8H10N2O

IUPAC Name:

3-amino-p-toluamide

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: HSD: Sprague Dawley SD
- Source: HARLAN WINKELMANN, SPF breeding stock
- Weight at study initiation: male: 188 - 206g (average 197g); female: 168 - 187g (average 179g)
- Age at start of study: 6 - 10 weeks
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Food: ssnif(8l R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

de-ionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 %

Doses:

1250, 1600, 2000 mg/kg bw (males only 2000 mg/kg bw)

No. of animals per sex per dose:

5 females; 5 males only in case of 2000 mg/kg bw

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of body weighing: 1/week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

1 727 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no lethality of any of the 5 male rats

Mortality:

Females: 1 of 5 at 1250 mg/kg bw, 1 of 5 at 1600 mg/kg bw, 4 of 5 at 2000 mg/kg bw; lethality occurred up to day five of the study.
Males: none detected

Clinical signs:

other: Unspecific symptoms the animals showed impairments of motility, respiration and consciousness. Additionally prone position, crawling forward, stupor and narrowed palpebral fissure were observed sporadically up to day four of the study.

Gross pathology:

Necropsy of the decedent animals revealed diffuse reddening of the small intestine
mucosa. The female animal of the 1250 mg/kg body weight dose group, which was
found dead, showed a dark red discolored lung.
The animals killed at the end of the observation period showed no macroscopically
visible changes.

Other findings:

The animals killed at the end of the observation period showed no macroscopically visible changes .

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was 1727mg/kg bw after single oral gavage in female rats.
Classification for acute oral toxicity according to EC 1272/2008: H302, Cat. 4

Executive summary:

Male and female Sprague Dawley were subjected to test acute oral toxicity. The test substance was administered by gavage.

The acute oral toxicity testing of 3 -amino-4-methylbenzamide in the rat yielded the following median lethal dose (LD50): Female animals: 1727 mg/kg body weight. Male animals did not show a higher sensitivity to the test substance.